AppetiteNCT05408390
Effects of Energy and Physical Density Manipulation on Appetite
A study testing LPD+LED, HPD+LED and LPD+HED in people with Appetite and Eating Behavior, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. Read more about this study
- Who is it for?
- Ages 17 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite, Eating Behavior
- What is being tested?
- LPD+LED, HPD+LED and LPD+HED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 4 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Body mass index (BMI) ≤ 30.0 kg/m2
- Willing to abstain from alcohol for 24 hours prior to and during days 1-2 of each study phase.
- Willing to abstain from strenuous exercise for 24 hours prior to and during days 1-2 of each study phase.
- Willing to abstain from a vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet) for two weeks prior to and throughout the study.
- Willing to maintain body weight throughout study.
- Willing to maintain usual diet (if not a restrictive diet), physical activity (aside from strenuous exercise limitation for 24 hours prior to and days 1-2 of each study phase) and nicotine use throughout study.
- Willing to abstain from dietary supplements (e.g., metabolism boosters, appetite suppressants, weight loss aids) impacting appetite or metabolism (as determined by study PI) throughout the study.
- Eats 3 meals per day at least 5 days/wk
Who cannot join
- Pregnant or lactating.
- Taking prescription medications, other than a contraceptive, known to affect appetite, digestion and/or metabolism (e.g., anti-diabetic agents) (unless approved by study PI)
- Any chronic medical condition that limits food intake or alters metabolism, appetite or digestive physiology (e.g., gastric bypass, gastrointestinal disease, dysphagia, diabetes).
- Allergies and intolerances (e.g. gluten, dairy, nuts), unwillingness or inability to eat provided foods and beverages.
- Score of ≥13 on the restraint scale or ≥9 on the disinhibition scale of the Eating Inventory
- Weight gain or loss of >5 lbs in the 2 weeks prior to study participation.
- Not willing or unable to adhere to all study procedures and restrictions.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have directly studied the interaction between physical and energy density manipulation. This study will determine the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability.
Read the detailed description
A historical challenge for military personnel operating in austere, remote environments is the ability to pack and carry enough food to sustain their operational and nutritional needs. To address this challenge and meet Army modernization requirements, US Army ration developers are developing a new ration to provide a lightweight, low volume, energy dense daily combat assault ration. The ration will use novel food processing techniques that remove air and water to reduce volume and increase physical density (g/cc) and will provide a high relative fat content to increase energy density (kcal/g or kcal/cc). As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have studied the independent effects on appetite and energy intake of increasing physical and energy densities of foods to the extent being targeted by the new ration, and none has directly studied the interaction between physical and energy density manipulation. This study will address that gap by determining the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability. Using a randomized, crossover design consisting of four separate phases, 20 participants will be provided with a standard base diet and experimental foods in which physical and energy density are systematically varied using different levels of mechanical compression and aeration, and different proportions of fat and carbohydrate, respectively. Consumption of the experimental foods at each of the physical and energy density combinations will be compulsory for 1 day while intake of the standard diet will be ad libitum. Total energy and macronutrient intake will be measured by collecting uneaten food items. Additionally, perceived appetite, gastrointestinal symptoms, fatigue and acceptability of the experimental food products will be measured by questionnaire.
- Conditions
- Appetite, Eating Behavior
- Being tested
- LPD+LED, HPD+LED, LPD+HED, HPD+HED
- Keywords
- Appetite, Eating behavior, Energy density
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPD+LEDOther
Low physical density (LPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and LED.
HPD+LEDOther
High physical density (HPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and LED.
LPD+HEDOther
Low physical density (LPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and HED.
HPD+HEDOther
High physical density (HPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and HED.
| Study group | Role | What they receive |
|---|---|---|
| Low physical and energy density | Experimental | Not described Receives: Other: LPD+LED |
| High physical and low energy density | Experimental | Not described Receives: Other: HPD+LED |
| Low physical and high energy density | Experimental | Not described Receives: Other: LPD+HED |
| High physical and energy density | Experimental | Not described Receives: Other: HPD+HED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total energy intake
Total energy intake from provided diet measured by weighing provided and uneaten foods.
Measured: Day 1 of each study arm.
Secondary outcomes (8)
Carbohydrate intake
Total carbohydrate intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Measured: Days 1 and 2 of each study arm
Protein intake
Total protein intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Measured: Days 1 and 2 of each study arm
Fat intake
Total fat intake from provided and self-selected diet measured by weighing provided and uneaten foods, and food records.
Measured: Days 1 and 2 of each study arm
Self reported energy intake
Energy intake from self-selected diet measured by food records.
Measured: Day 2 of each study arm
Appetite
Hunger, fullness, desire to eat and prospective consumption measured by 100mm visual analog scale. Range is 0 to 100, with higher scores indicating greater hunger/fullness/desire/prospective consumption.
Measured: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Fatigue
Level of fatigue measured by integer scale ranging from 0 (not tired) to 10 (total exhaustion)
Measured: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Gastrointestinal symptoms
Heartburn, bloating, abdominal pain, urge to vomit, nausea, gas, urge to defecate, overall gastrointestinal discomfort measured by 100mm visual analog scale. Range 0 (none) to 100 (extremely severe).
Measured: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Acceptability
Appearance, odor, flavor, texture, and overall acceptability of experimental foods rated on scale ranging from 1 (dislike extremely) to 9 (like extremely).
Measured: At breakfast, lunch and afternoon snack on day 1 of each study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start5 Jul 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, single-blind, crossover study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- US Army Research and Development Command- Soldier Center
- Responsible party
- Sponsor
- Investigators
- J. Philip Karl, Principal investigator, US Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408390
- Sponsor's protocol ID
- 22-03HC
- Other IDs
- M-10975
- Status last verified
- Aug 2023
- First submitted
- 24 May 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy and Physical Density Manipulation on Appetite
- ClinicalTrials.gov ID
- NCT05408390
- Acronym / sponsor ID
- 22-03HC
- Conditions
- Appetite, Eating Behavior
- Keywords
- Appetite, Eating behavior, Energy density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- US Army Research and Development Command- Soldier Center
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have directly studied the interaction between physical and energy density manipulation. This study will determine the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability.
Detailed description
A historical challenge for military personnel operating in austere, remote environments is the ability to pack and carry enough food to sustain their operational and nutritional needs. To address this challenge and meet Army modernization requirements, US Army ration developers are developing a new ration to provide a lightweight, low volume, energy dense daily combat assault ration. The ration will use novel food processing techniques that remove air and water to reduce volume and increase physical density (g/cc) and will provide a high relative fat content to increase energy density (kcal/g or kcal/cc). As individuals tend to eat a constant weight or volume of food, manipulating physical and energy densities generally results in changes in energy intake without affecting subjective appetite sensations. However, relatively few studies have studied the independent effects on appetite and energy intake of increasing physical and energy densities of foods to the extent being targeted by the new ration, and none has directly studied the interaction between physical and energy density manipulation. This study will address that gap by determining the effects of foods that systematically vary in physical and energy density on ad libitum energy intake and subjective appetite ratings. Secondary outcomes will include gastrointestinal discomfort, fatigue and acceptability. Using a randomized, crossover design consisting of four separate phases, 20 participants will be provided with a standard base diet and experimental foods in which physical and energy density are systematically varied using different levels of mechanical compression and aeration, and different proportions of fat and carbohydrate, respectively. Consumption of the experimental foods at each of the physical and energy density combinations will be compulsory for 1 day while intake of the standard diet will be ad libitum. Total energy and macronutrient intake will be measured by collecting uneaten food items. Additionally, perceived appetite, gastrointestinal symptoms, fatigue and acceptability of the experimental food products will be measured by questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Randomized, single-blind, crossover study
| Arm | Type | Receives |
|---|---|---|
| Low physical and energy density | Experimental | Other: LPD+LED |
| High physical and low energy density | Experimental | Other: HPD+LED |
| Low physical and high energy density | Experimental | Other: LPD+HED |
| High physical and energy density | Experimental | Other: HPD+HED |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) ≤ 30.0 kg/m2
- Willing to abstain from alcohol for 24 hours prior to and during days 1-2 of each study phase.
- Willing to abstain from strenuous exercise for 24 hours prior to and during days 1-2 of each study phase.
- Willing to abstain from a vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet) for two weeks prior to and throughout the study.
- Willing to maintain body weight throughout study.
Key exclusion criteria (7 listed)
- Pregnant or lactating.
- Taking prescription medications, other than a contraceptive, known to affect appetite, digestion and/or metabolism (e.g., anti-diabetic agents) (unless approved by study PI)
- Any chronic medical condition that limits food intake or alters metabolism, appetite or digestive physiology (e.g., gastric bypass, gastrointestinal disease, dysphagia, diabetes).
- Allergies and intolerances (e.g. gluten, dairy, nuts), unwillingness or inability to eat provided foods and beverages.
- Score of ≥13 on the restraint scale or ≥9 on the disinhibition scale of the Eating Inventory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPD+LEDLow physical density (LPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and LED. | Other | Low physical and energy density |
| HPD+LEDHigh physical density (HPD) + low energy density (LED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and LED. | Other | High physical and low energy density |
| LPD+HEDLow physical density (LPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have LPD and HED. | Other | Low physical and high energy density |
| HPD+HEDHigh physical density (HPD) + high energy density (HED) foods. Participants receive breakfast, lunch and snack items engineered to have HPD and HED. | Other | High physical and energy density |
Primary outcome
Total energy intake
Time frame: Day 1 of each study arm.
Total energy intake from provided diet measured by weighing provided and uneaten foods.
8 secondary outcomes
Carbohydrate intake
Time frame: Days 1 and 2 of each study arm
Protein intake
Time frame: Days 1 and 2 of each study arm
Fat intake
Time frame: Days 1 and 2 of each study arm
Self reported energy intake
Time frame: Day 2 of each study arm
Appetite
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Fatigue
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Gastrointestinal symptoms
Time frame: Immediately before, immediately after and 15 min after breakfast, lunch and afternoon snack on day 1 of each study arm
Acceptability
Time frame: At breakfast, lunch and afternoon snack on day 1 of each study arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Appetite
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
RecruitingObservational study
An Open Label Pilot Study Assessing the Impact of Chromium Picolinate Supplementation on Appetite and Cravings in Overweight Individuals
Overweight (BMI > 25), Appetite
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Philip Karl principal investigator
US Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LPD+LED, HPD+LED and LPD+HED in people with Appetite and Eating Behavior, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total energy intake (time frame: Day 1 of each study arm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.